Esophagogastric VaricesNCT07253090
EUS-PPG Alteration After Ligation and Sclerotherapy in Esophageal Varices
A study testing Sclerotherapy for esophageal varices and Ligation for esophageal varices in people with Esophagogastric Varices, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Acute variceal bleeding due to cirrhotic portal hypertension is a life-threatening emergency in gastroenterology. Current preventive strategies include non-selective β-blockers (e.g., carvedilol/propranolol), endoscopic therapy (sclerotherapy or band ligation), and transjugular intrahepatic portosystemic shunt (TIPS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophagogastric Varices
- What is being tested?
- Sclerotherapy for esophageal varices and Ligation for esophageal varices
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patients admitted for primary/secondary prevention due to esophageal and gastric varices, and willing to sign the informed consent form.
Who cannot join
- Refusing to sign the informed consent form;
- Age < 18 years, or ≥ 81 years;
- Coagulopathy (INR > 1.5);
- Markedly decreased platelets (<20,000/μL);
- Propranolol/carvedilol was used 24h before admission.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
About this study
Official title: The Comparative Study on the Alteration of Endoscopic Ultrasound Guided Portal Pressure Gradient in Esophageal Varices After Ligation and Sclerotherapy
Acute variceal bleeding due to cirrhotic portal hypertension is a life-threatening emergency in gastroenterology. Current preventive strategies include non-selective β-blockers (e.g., carvedilol/propranolol), endoscopic therapy (sclerotherapy or band ligation), and transjugular intrahepatic portosystemic shunt (TIPS). While pharmacological and TIPS interventions directly reduce portal pressure, the impact of endoscopic therapies on portal hemodynamics remains controversial. The hepatic venous pressure gradient (HVPG), measured via transjugular catheterization as the difference between wedged and free hepatic venous pressures, is the gold standard for assessing portal pressure. Clinically significant portal hypertension (CSPH) is defined as HVPG ≥10 mmHg, with values >12 mmHg predicting variceal formation and bleeding risk.
Traditional views suggest that non-selective β-blockers and transjugular intrahepatic portosystemic shunt (TIPS) can reduce portal vein pressure. Does endoscopic intervention affect portal vein pressure? Previous studies have explored changes in HVPG in the acute phase after esophageal variceal sclerotherapy and ligation therapy, with inconsistent results. In the study by Toyonaga et al., HVPG was rechecked 2 weeks after sclerotherapy, and the average decreased from 17.9 mmHg to 17.6 mmHg (J Hepatol. 1994 Oct;21(4):515-20). In the study by Gonzalo Bada et al., HVPG values increased from 16.5 mmHg to 19.5 mmHg on average 24 hours after ligation therapy (Rev Esp Enferm Dig. 2020 Jun;112(6):456-461). However, in a prospective randomized controlled study conducted by Avgerinos et al., which compared changes in HVPG within 5 days after ligation and sclerotherapy, and found that HVPG significantly increased after sclerotherapy, while there was no significant change in HVPG after ligation (Hepatology. 2004 Jun;39(6):1623-30).
Read more
The investigators speculate that the inconsistent results mentioned above may be related to the limitations of HVPG, which inaccurately reflects pre-sinusoidal/extrahepatic portal hypertension and is influenced by technical factors (e.g., catheter position, sedation). Emerging evidence suggests endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement may overcome these limitations. Recent studies demonstrate strong correlations between EUS-PPG and HVPG, as well as associations with variceal severity and Child-Pugh class. However, data on chronic portal pressure changes (≥3 months) post-endoscopic therapy are lacking.
This prospective study aims to evaluate chronic changes in EUS-PPG 3-6 months after endoscopic variceal ligation (EVL) or sclerotherapy in cirrhotic patients receiving primary/secondary prophylaxis.
- Conditions
- Esophagogastric Varices
- Being tested
- Sclerotherapy for esophageal varices, Ligation for esophageal varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sclerotherapy for esophageal varicesProcedure or surgery
EUS-PPG alteration in esophageal varices after sclerotherapy
Ligation for esophageal varicesProcedure or surgery
EUS-PPG alteration in esophageal varices after Ligation
| Study group | Role | What they receive |
|---|---|---|
| EUS-PPG alteration in esophageal varices after ligation | Other | Not described Receives: Procedure: Ligation for esophageal varices |
| EUS-PPG alteration in esophageal varices after sclerotherapy | Experimental | Not described Receives: Procedure: Sclerotherapy for esophageal varices |
What is being measured
The primary outcome is the main question the study is designed to answer.
The altered value of portal vein pressure gradient measured under EUS after sclerotherapy or ligation for esophegeal varices
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start18 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastric VaricesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253090
- Sponsor's protocol ID
- 2025-0708
- Status last verified
- Jul 2025
- First submitted
- 17 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Study on the Alteration of Endoscopic Ultrasound Guided Portal Pressure Gradient in Esophageal Varices After Ligation and Sclerotherapy
- ClinicalTrials.gov ID
- NCT07253090
- Acronym / sponsor ID
- 2025-0708
- Conditions
- Esophagogastric Varices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute variceal bleeding due to cirrhotic portal hypertension is a life-threatening emergency in gastroenterology. Current preventive strategies include non-selective β-blockers (e.g., carvedilol/propranolol), endoscopic therapy (sclerotherapy or band ligation), and transjugular intrahepatic portosystemic shunt (TIPS). While pharmacological and TIPS interventions directly reduce portal pressure, the impact of endoscopic therapies on portal hemodynamics remains controversial. The hepatic venous pressure gradient (HVPG), measured via transjugular catheterization as the difference between wedged and free hepatic venous pressures, is the gold standard for assessing portal pressure. Clinically significant portal hypertension (CSPH) is defined as HVPG ≥10 mmHg, with values >12 mmHg predicting variceal formation and bleeding risk.
Traditional views suggest that non-selective β-blockers and transjugular intrahepatic portosystemic shunt (TIPS) can reduce portal vein pressure. Does endoscopic intervention affect portal vein pressure? Previous studies have explored changes in HVPG in the acute phase after esophageal variceal sclerotherapy and ligation therapy, with inconsistent results. In the study by Toyonaga et al., HVPG was rechecked 2 weeks after sclerotherapy, and the average decreased from 17.9 mmHg to 17.6 mmHg (J Hepatol. 1994 Oct;21(4):515-20). In the study by Gonzalo Bada et al., HVPG values increased from 16.5 mmHg to 19.5 mmHg on average 24 hours after ligation therapy (Rev Esp Enferm Dig. 2020 Jun;112(6):456-461). However, in a prospective randomized controlled study conducted by Avgerinos et al., which compared changes in HVPG within 5 days after ligation and sclerotherapy, and found that HVPG significantly increased after sclerotherapy, while there was no significant change in HVPG after ligation (Hepatology. 2004 Jun;39(6):1623-30).
The investigators speculate that the inconsistent results mentioned above may be related to the limitations of HVPG, which inaccurately reflects pre-sinusoidal/extrahepatic portal hypertension and is influenced by technical factors (e.g., catheter position, sedation). Emerging evidence suggests endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement may overcome these limitations. Recent studies demonstrate strong correlations between EUS-PPG and HVPG, as well as associations with variceal severity and Child-Pugh class. However, data on chronic portal pressure changes (≥3 months) post-endoscopic therapy are lacking.
This prospective study aims to evaluate chronic changes in EUS-PPG 3-6 months after endoscopic variceal ligation (EVL) or sclerotherapy in cirrhotic patients receiving primary/secondary prophylaxis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-PPG alteration in esophageal varices after ligation | Other | Procedure: Ligation for esophageal varices |
| EUS-PPG alteration in esophageal varices after sclerotherapy | Experimental | Procedure: Sclerotherapy for esophageal varices |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cirrhotic patients admitted for primary/secondary prevention due to esophageal and gastric varices, and willing to sign the informed consent form.
Key exclusion criteria (5 listed)
- Refusing to sign the informed consent form;
- Age < 18 years, or ≥ 81 years;
- Coagulopathy (INR > 1.5);
- Markedly decreased platelets (<20,000/μL);
- Propranolol/carvedilol was used 24h before admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sclerotherapy for esophageal varicesEUS-PPG alteration in esophageal varices after sclerotherapy | Procedure or surgery | EUS-PPG alteration in esophageal varices after sclerotherapy |
| Ligation for esophageal varicesEUS-PPG alteration in esophageal varices after Ligation | Procedure or surgery | EUS-PPG alteration in esophageal varices after ligation |
Primary outcome
The altered value of portal vein pressure gradient measured under EUS after sclerotherapy or ligation for esophegeal varices
Time frame: 3-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sclerotherapy for esophageal varices and Ligation for esophageal varices in people with Esophagogastric Varices, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Xue (+86 0571 87783544, xuemeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The altered value of portal vein pressure gradient measured under EUS after sclerotherapy or ligation for esophegeal varices (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.